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Understanding Ketamine's Dissociative Effects (KD Study)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04861051
Recruitment Status : Recruiting
First Posted : April 27, 2021
Last Update Posted : September 23, 2021
Sponsor:
Information provided by (Responsible Party):
Karl Deisseroth, Stanford University

Brief Summary:
The purpose of this study is to understand how ketamine brings about dissociative symptoms.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Ketamine Phase 1

Detailed Description:
The goal of this proposed research is to record the effects of ketamine on brain activity to understand the changes that occur during dissociation in epilepsy patients with stereoEEG.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Understanding Ketamine's Dissociative Effects in Epilepsy (KD Study)
Actual Study Start Date : July 26, 2021
Estimated Primary Completion Date : August 1, 2023
Estimated Study Completion Date : August 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
Drug Information available for: Ketamine

Arm Intervention/treatment
Ketamine
Study participants will receive 0.5mg/kg of ketamine - one single infusion
Drug: Ketamine
Study participants will receive 0.5mg/kg of ketamine - one single infusion
Other Name: Ketalar




Primary Outcome Measures :
  1. Number of participants with dissociative events during ketamine infusion as assessed by CADSS (Clinician-Administered Dissociative State Scale) [ Time Frame: up to 1 week ]
    The CADSS is an instrument for the measurement of dissociative symptoms. The CADSS comprises 23 subjective items and participant's responses are coded on a 5-point scale (0 = Not at all; 4 = Extreme). The higher the number on the CADSS, the more severe the symptoms.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient in Stanford Epilepsy Monitoring Unit
  • Age >18 years old.

Exclusion Criteria:

  • Lifetime psychotic or bipolar disorder
  • Inability to speak, read or understand English
  • Pregnant or nursing females
  • Prior adverse ketamine response

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04861051


Contacts
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Contact: Pavithra Mukunda, MS 6504972578 pavithra.mukunda@stanford.edu

Locations
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United States, California
Stanford University School of Medicine Recruiting
Palo Alto, California, United States, 94305
Contact: Karl Deisseroth, MD, PhD         
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Karl Deisseroth, MD, PhD Stanford University
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Responsible Party: Karl Deisseroth, Professor of Bioengineering and of Psychiatry and Behavioral Sciences, Stanford University
ClinicalTrials.gov Identifier: NCT04861051    
Other Study ID Numbers: 60085
First Posted: April 27, 2021    Key Record Dates
Last Update Posted: September 23, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action